The shelf life of liquid-stored platelets is about 5 to 7 days, which limits their availability and causes waste. Thus, this study evaluated the safety and efficacy of dimethyl sulfoxide-cryopreserved platelets, which have a 2-year shelf life, as a therapy for bleeding following heart surgery.
Patients were enrolled in the Cryopreserved vs. Liquid Platelets II (CLIP-II) in the experiment at 11 Australian tertiary institutions between August 2021 and April 2024. The trial's follow-up was finished in July 2024. Individuals who were at high risk of receiving a platelet transfusion were qualified.
The patients were ruled out if they had a history of deep vein thrombosis or pulmonary embolism, were coagulopathic, or were females aged 18 to 55 years who were rhesus D (RhD) negative or of unclear RhD status. Of the 879 patients who met the inclusion criteria, 412 remained after 182 were eliminated and 285 refused to provide their permission. Of them, 202 were given study platelets and 388 were randomized.
Starting intraoperatively or during the first 24 hours following surgery, patients were given up to 3 units of either conventional liquid-stored platelets or group O cryopreserved platelets. Postoperative chest drain bleeding over the first 24 hours after admission to the critical care unit was the main consequence. Less than 20% more bleeding throughout this time was the prospective definition of noninferiority. 42 tertiary and five secondary outcomes were predetermined.
For perioperative hemorrhage, cryopreserved platelets did not satisfy noninferiority requirements when compared to liquid-stored platelets. Overall blood loss was somewhat greater with cryopreserved platelets (605 vs. 535 mL) among 202 transfused patients (mean age 64 years; ~76% male), and confidence intervals passed the noninferiority limit.
The use of cryopreserved platelets was associated with increased needs for red blood cells, plasma, and cryoprecipitate as well as noticeably higher intraoperative and overall perioperative blood loss. The patients receiving cryopreserved platelets had longer breathing periods and longer ICU and hospital admissions, indicating a more complicated postoperative course despite equivalent safety profiles, even if adverse event rates were equal between groups.
Overall, at 24 hours following ICU admission, cryopreserved platelets failed to achieve the predetermined criterion for noninferiority in hemostatic efficacy. While prespecified adverse events were similar, additional predetermined end points consistently showed reduced hemostatic efficacy.
Source:
Reade, M. C., Marks, D. C., Howe, B. D., Bailey, M. J., Bannon, P. G., Eastwood, G. M., French, C. J., Gattas, D. J., Higgins, A. M., Holley, A. D., Hu, R. T., Irving, D. O., Johnson, L., McGuinness, S. P., McQuilten, Z. K., Royse, A. G., Smith, J. A., Weinberg, L., Wood, E. M., … Cryopreserved vs Liquid Platelets II (CLIP-II) Investigators, the Australian and New Zealand Intensive Care Society Clinical Trials Group, the Australian and New Zealand College of Anaesthetists Clinical Trials Network, and the Australasian Society of Cardiac and Thoracic Surgeons. (2025). Cryopreserved vs liquid-stored platelets for the treatment of surgical bleeding: The CLIP-II randomized noninferiority clinical trial: The CLIP-II randomized noninferiority clinical trial. JAMA: The Journal of the American Medical Association. https://doi.org/10.1001/jama.2025.23355
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